(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis

Completed · Phase 2 · Has a placebo group

Conditions studied: Abdominal Pain

In brief

The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.

Key facts

Study ID

NCT00932737

Run by

Boehringer Ingelheim

People needed

197

Starts

2009-06-09

Expected to finish

2010-02-08

Last updated by the study team

2022-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of recurrent abdominal pain with cramping (APC) for at least three months.
• Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

You may not qualify if…

• Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).

Where it is running

• 202.839.01014 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
• 202.839.01003 Boehringer Ingelheim Investigational Site — Hollywood, Florida, United States
• 202.839.01001 Boehringer Ingelheim Investigational Site — Jupiter, Florida, United States
• 202.839.01002 Boehringer Ingelheim Investigational Site — Jupiter, Florida, United States
• 202.839.01017 Boehringer Ingelheim Investigational Site — Rockford, Illinois, United States
• 202.839.01005 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 202.839.01019 Boehringer Ingelheim Investigational Site — Chevy Chase, Maryland, United States
• 202.839.01009 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 202.839.01004 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
• 202.839.01011 Boehringer Ingelheim Investigational Site — Toms River, New Jersey, United States
• 202.839.01008 Boehringer Ingelheim Investigational Site — Lake Success, New York, United States
• 202.839.01015 Boehringer Ingelheim Investigational Site — Cleveland, Ohio, United States
• 202.839.01021 Boehringer Ingelheim Investigational Site — Norman, Oklahoma, United States
• 202.839.01010 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 202.839.01013 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 202.839.01006 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 202.839.01012 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 202.839.01007 Boehringer Ingelheim Investigational Site — Virginia Beach, Virginia, United States
• 202.839.01020 Boehringer Ingelheim Investigational Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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